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ACTiF- Assessment of Closed Tibial Fractures

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wichita, Kansas, 67214 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tibial Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females 17 years or older with confirmed closure of the tibial epiphyses,
with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked
IM nailing procedure and the absence of an associated compartment syndrome or vascular
injury;

- Closed tibial fractures Types A, B & C (See OTA fracture classification) can be
included.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous fractures of the same tibia that may impact nailing procedure or impaired
visibility of current fracture or a history of osteomyelitis;

- Subjects with any other clinically significant injuries, which may significantly
impair weight bearing of the affected limb;

- Subjects with a fracture gap of >1cm after initial surgery and prior to drug
administration;

- Any other planned invasive or non invasive interventions intended to promote bone
healing of the tibial fracture under study are not allowed in the first 24 weeks after
treatment.

NCT00533377
Pfizer
Completed
ACTiF- Assessment of Closed Tibial Fractures

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ACTiF- Assessment of Closed Tibial Fractures
A Randomized, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of CP-533,536 In Subjects With Closed Fracture Of The Tibial Shaft
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tibial Fractures
  • Drug: CP-533, 536
    Active study drug
  • Drug: Placebo
    Placebo vehicle
  • Procedure: Standard of Care
    Standard surgical procedure
  • Drug: CP-533,536
    Active study drug
  • Experimental: CP-533,536 Dose Level 2
    Intervention: Drug: CP-533, 536
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Standard of Care
    Intervention: Procedure: Standard of Care
  • Experimental: CP-533,536 Dose Level 1
    Intervention: Drug: CP-533,536
  • Experimental: CP-533,536 Dose Level 3
    Intervention: Drug: CP-533,536
  • Experimental: CP-533.536 Dose Level 4
    Intervention: Drug: CP-533,536
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
  • Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.

Exclusion Criteria:

  • Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
  • Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
  • Subjects with a fracture gap of >1cm after initial surgery and prior to drug administration;
  • Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Bosnia and Herzegovina,   Canada,   Croatia,   India,   Japan,   Russian Federation,   South Africa,   Spain,   Turkey,   United States
 
 
NCT00533377
A3241010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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